Cra
hace 5 meses
Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts monitoring tasks in accordance with the approved monitoring plan. Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable.Participates in investigator meetings as necessary. Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Performs trial close out and retrieval of trial materials.Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System).Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts.
Responds to company, client and applicable regulatory requirements/audits/inspections.Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.Contributes to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members.Contributes to other project work and initiatives for process improvement, as required.
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Cra Manager
hace 4 meses
Santiago de Chile MSD A tiempo completo**Job Description**: Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us. Our ability to excel depends on the integrity, knowledge, imagination, skill,...
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Assistant Cra
hace 4 meses
Santiago de Chile Thermo Fisher Scientific A tiempo completo**Description - External** We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD clinical research services — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to...
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Assistant Cra
hace 4 meses
Santiago de Chile Thermo Fisher Scientific A tiempo completoWe are vital links between an idea for a new medicine and the people who need it. We are the people of PPD clinical research services — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve...
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Cra Ii
hace 3 meses
Santiago de Chile ICON plc A tiempo completoAs a CRA you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. A CRA is a professional who contributes to accelerated drug/device/outcomes research through independent monitoring of studies to ensure patient safety and data integrity. You will be partnering with one of our global...
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Cra Ii
hace 4 meses
Santiago de Chile ICON plc A tiempo completo**Experienced CRA - Santiago, Chile, home-based role** ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre...
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Sr Cra
hace 4 meses
Santiago de Chile Fortrea A tiempo completoAs a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...
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Cra Ii
hace 4 meses
Santiago de Chile ICON A tiempo completoAs Clinical Research Associate (CRA), you will be joining the world's largest & most comprehensive clinical research organization, powered by healthcare intelligence. You will be dedicated resource to one of our clients, be embedded in their working environment, systems and processes. You will be engaged in a wide range of interesting and challenging...
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Senior Cra
hace 3 meses
Santiago de Chile ICON plc A tiempo completoAs Clinical Research Associate (CRA), you will be joining the world's largest & most comprehensive clinical research organization, powered by healthcare intelligence. A CRA is a professional who contributes to accelerated drug/device/outcomes research through independent monitoring of studies to ensure patient safety and data integrity. You will be...
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Cra I
hace 4 meses
Santiago de Chile ICON plc A tiempo completoICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations. With our patients at the center of all that we do, we help to accelerate the development...
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Cra Ii
hace 2 semanas
Santiago de Chile Icon plc A tiempo completoCRA II - Santiago, Chile - Remote ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development At ICON, it’s our people that set us apart. Our diverse teams...
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Senior Cra
hace 2 semanas
Santiago de Chile Icon plc A tiempo completoSenior CRA - Santiago, Chile - Remote ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development At ICON, it’s our people that set us apart. Our diverse...
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Cra I
hace 4 meses
Santiago de Chile Fortrea A tiempo completoSite monitoring and site management responsibility for clinical studies according to Company, and/or Sponsor, Standard Operating Procedures, and Regulatory Guidelines. Assures the implementation of project plans, as assigned. Essential Job Duties: 1) Responsible for all aspects of study site monitoring including routine monitoring and closeout of clinical...
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Cra I
hace 4 meses
Santiago de Chile ICON A tiempo completoICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. A CRA is a professional who contributes to accelerated drug/device/outcomes research through...
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Cra Ii
hace 4 meses
Santiago de Chile ICON plc A tiempo completoICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. A CRA is a professional who contributes to accelerated drug/device/outcomes research through...
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Senior Cra
hace 3 meses
Santiago de Chile ICON plc A tiempo completoICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. A CRA is a professional who contributes to accelerated drug/device/outcomes research through...
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Cra 1
hace 5 meses
Santiago de Chile Novasyte A tiempo completoJob Overview Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements. Essential Functions - Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance...
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Cra Ii
hace 4 meses
Santiago de Chile ICON plc A tiempo completoICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development...
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Cra Ii
hace 4 meses
Santiago de Chile ICON plc A tiempo completoICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development...
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Cra Ii
hace 4 meses
Santiago de Chile ICON plc A tiempo completoICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations. With our patients at the center of all that we do, we help to accelerate the development...
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Cra Ii
hace 3 meses
Santiago de Chile ICON plc A tiempo completoICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development...
